Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial

Antalya Training and Research Hospital1 site in 1 country80 target enrollmentJanuary 8, 2019

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Antalya Training and Research Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: Rate of objective cure
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse

Registry

clinicaltrials.gov

Start Date

January 8, 2019

End Date

January 22, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Antalya Training and Research Hospital

Responsible Party

Principal Investigator

bekirsitkiisenlik

principal investigator

Antalya Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

•Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management

Exclusion Criteria

•Patients that are not candidates for general anesthesia or laparoscopy
•Inability to consent
•history of hysterectomy
•history of anterior or apical pelvic organ prolapse surgery
•history of urinary incontinence surgery
•pregnancy or breast-feeding during the study period
•suspicious adnexal masses or other factors that may indicate pelvic malignancy

Outcomes

Primary Outcomes

Rate of objective cure

Time Frame: 12 months

Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system

Secondary Outcomes

Patient Global Impression of Improvement (PGI-I)(12 months)
International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)(12 months)
International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)(12 months)